Background supporting material

Before considering a particular decision-making scenario you might like to review some general background material relevant to using real-world evidence (RWE) in medicine development. Choose from the menu of topics below:

Decision-making perspective

There are a number of decision makers involved in medicines development. While GetReal primarily focuses on pharmaceutical research and development (R&D), regulatory and health technology assessment (HTA) perspectives, the patient perspective, clinician and local payer perspectives are also important.

Evidence development pathways

The combinations and sequences of studies that feature in a standard evidence development pathway for a medicine are primarily aimed at regulatory approval. Alternative pathways for studies may help improve the generation of evidence of relative effectiveness, which is of central importance to decision makers.

Policies and perspectives

Impact of RWE on re-assessment of medicines by HTA agencies

The use of real-world evidence (RWE) is important for access and reimbursement decisions for a number of reasons including that it may help to gain a better understanding of the patient population who will receive a medicine; it may also help to better understand the relative effectiveness of medicines by supplementing evidence from conventional randomised controlled trials (RCTs).

Funding

The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement no [115546], resources of which are composed of financial contribution from the European Union's Seventh Framework Programme (FP7/2007-2013) and EFPIA companies in kind contribution.